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Adverse reactions to HIV vaccines : medical, ethical, and legal issues
Adverse reactions to HIV vaccines : medical, ethical, and legal issues
Pubbl/distr/stampa Washington : Office of Technology Assessment
Disciplina 616.97/92061
Soggetto topico AIDS vaccines - United States
AIDS (Disease) - Vaccination - Complications
HIV infections - Risk factors - United States
Human experimentation in medicine - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Adverse Reactions to HIV Vaccines
Record Nr. UNINA-9910689358803321
Washington : Office of Technology Assessment
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Biospecimen research : meeting basic human subjects protection requirements and communicating informational risks
Biospecimen research : meeting basic human subjects protection requirements and communicating informational risks
Pubbl/distr/stampa [Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 2013
Descrizione fisica 1 online resource (25 pages) : illustrations
Soggetto topico Medical records - Access control - United States
Human experimentation in medicine - United States
Privacy, Right of - United States
Clinical trials - Access control - United States
Preservation of organs, tissues, etc - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Biospecimen research
Record Nr. UNINA-9910707453303321
[Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 2013
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Contemporary issues for protecting patients in cancer research : workshop summary / / Institute of Medicine (U.S.) ; Sharyl J. Nass and Margie Patlak, Rapporteurs National Cancer Policy Forum Board on Health Care Services
Contemporary issues for protecting patients in cancer research : workshop summary / / Institute of Medicine (U.S.) ; Sharyl J. Nass and Margie Patlak, Rapporteurs National Cancer Policy Forum Board on Health Care Services
Autore Nass Sharyl J.
Pubbl/distr/stampa Washington, District of Columbia : , : National Academies Press, , 2014
Descrizione fisica 1 online resource (92 pages) : illustrations
Disciplina 174.28
Soggetto topico Human experimentation in medicine - United States
Human experimentation in medicine - Moral and ethical aspects - United States
Patients - Civil rights - United States
ISBN 0-309-30669-8
0-309-30667-1
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Introduction -- Current regulatory arena -- Common rule and HIPAA -- Shortcomings of current regulations and guidances -- Context -- Data deindentification -- Impediment to quality improvement and learning -- Varied interpretation -- Misaligned incentives -- Lack of harmonization with international standards -- Informed consent forms -- Informed consent process -- Consent tools -- Beyond consent -- HITECH -- Advanced notice of proposed rulemaking -- Patient perspectives on research protections -- Ethical challenges of genetic advances -- Patient consent for use of archived biospecimens -- Return of research results -- Clinically actionable findings -- Context matters -- Who pays -- Biospecimens from deceased participants -- The changing context of research and care -- Oversight in a learning health care system -- Oversight of pragmatic trials -- Multisite studies and IRB review -- Central IRBs -- New England Reliance Agreement -- Value of local IRBs -- Educational needs -- Research needs -- Wrap-up.
Record Nr. UNINA-9910787154803321
Nass Sharyl J.  
Washington, District of Columbia : , : National Academies Press, , 2014
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Contemporary issues for protecting patients in cancer research : workshop summary / / Institute of Medicine (U.S.) ; Sharyl J. Nass and Margie Patlak, Rapporteurs National Cancer Policy Forum Board on Health Care Services
Contemporary issues for protecting patients in cancer research : workshop summary / / Institute of Medicine (U.S.) ; Sharyl J. Nass and Margie Patlak, Rapporteurs National Cancer Policy Forum Board on Health Care Services
Autore Nass Sharyl J.
Pubbl/distr/stampa Washington, District of Columbia : , : National Academies Press, , 2014
Descrizione fisica 1 online resource (92 pages) : illustrations
Disciplina 174.28
Soggetto topico Human experimentation in medicine - United States
Human experimentation in medicine - Moral and ethical aspects - United States
Patients - Civil rights - United States
ISBN 0-309-30669-8
0-309-30667-1
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Introduction -- Current regulatory arena -- Common rule and HIPAA -- Shortcomings of current regulations and guidances -- Context -- Data deindentification -- Impediment to quality improvement and learning -- Varied interpretation -- Misaligned incentives -- Lack of harmonization with international standards -- Informed consent forms -- Informed consent process -- Consent tools -- Beyond consent -- HITECH -- Advanced notice of proposed rulemaking -- Patient perspectives on research protections -- Ethical challenges of genetic advances -- Patient consent for use of archived biospecimens -- Return of research results -- Clinically actionable findings -- Context matters -- Who pays -- Biospecimens from deceased participants -- The changing context of research and care -- Oversight in a learning health care system -- Oversight of pragmatic trials -- Multisite studies and IRB review -- Central IRBs -- New England Reliance Agreement -- Value of local IRBs -- Educational needs -- Research needs -- Wrap-up.
Record Nr. UNINA-9910811817703321
Nass Sharyl J.  
Washington, District of Columbia : , : National Academies Press, , 2014
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Contemporary issues for protecting patients in cancer research : workshop summary / / Institute of Medicine (U.S.) ; Sharyl J. Nass and Margie Patlak, Rapporteurs National Cancer Policy Forum Board on Health Care Services
Contemporary issues for protecting patients in cancer research : workshop summary / / Institute of Medicine (U.S.) ; Sharyl J. Nass and Margie Patlak, Rapporteurs National Cancer Policy Forum Board on Health Care Services
Pubbl/distr/stampa Washington, District of Columbia : , : National Academies Press, , 2014
Descrizione fisica 1 online resource (92 pages) : illustrations
Disciplina 174.28
Soggetto topico Human experimentation in medicine - United States
Human experimentation in medicine - Moral and ethical aspects - United States
Patients - Civil rights - United States
Soggetto genere / forma Electronic books.
ISBN 0-309-30667-1
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Record Nr. UNINA-9910460146203321
Washington, District of Columbia : , : National Academies Press, , 2014
Materiale a stampa
Lo trovi qui: Univ. Federico II
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FDA oversight of clinical investigators
FDA oversight of clinical investigators
Pubbl/distr/stampa [Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 2000
Descrizione fisica 1 online resource (25 pages) : illustration
Soggetto topico Human experimentation in medicine - United States
Clinical trials - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Food and Drug Administration oversight of clinical investigators
Oversight of clinical investigators
Record Nr. UNINA-9910707660103321
[Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 2000
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Final report of the Advisory Committee on Human Radiation Experiments
Final report of the Advisory Committee on Human Radiation Experiments
Pubbl/distr/stampa New York, New York ; ; Oxford, [England] : , : Oxford University Press, , 1996
Descrizione fisica 1 online resource (655 p.)
Disciplina 616.9897
Soggetto topico Human experimentation in medicine - United States
Radiotherapy - United States
Nuclear medicine - United States
Medical ethics - United States
Radiation victims - United States
Gene therapy - United States
Soggetto genere / forma Electronic books.
ISBN 0-19-977140-5
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cover; Contents; Remarks; Preface; Introduction: The Atomic Century; PART I: Ethics of Human Subjects Research: A Historical Perspective; Overview; 1. Government Standards for Human Experiments: The 1940s and 1950s; 2. Postwar Professional Standards and Practices for Human Experiments; 3. Government Standards for Human Experiments: The 1960s and 1970s; 4. Ethics Standards in Retrospect; PART II: Case Studies; Overview; 5. Experiments with Plutonium, Uranium, and Polonium; 6. The AEC Program of Radioisotope Distribution; 7. Nontherapeutic Research on Children
8. Total-Body Irradiation: Problems When Research and Treatment Are Intertwined9. Prisoners: A Captive Research Population; 10. Atomic Veterans: Human Experimentation in Connection with Bomb Tests; 11. Intentional Releases: Lifting the Veil of Secrecy; 12. Observational Data Gathering; 13. Secrecy, Human Radiation Experiments, and Intentional Releases; PART III: Contemporary Projects; Overview; 14. Current Federal Policies Governing Human Subjects Research; 15- Research Proposal Review Project; 16. Subject Interview Study; Discussion of Part III
PART IV: Coming to Terms with the Past, Looking Ahead to the FutureOverview; 17. Findings; 18. Recommendations; STATEMENT BY COMMITTEE MEMBER JAY KATZ; OFFICIAL DOCUMENTS; Executive Order; Charter; APPENDICES; Acronyms and Abbreviations; Glossary; A; B; C; D; E; F; G; H; I; L; M; N; P; R; T; U; X; Selected Bibliography; Public Comment Participants; A Citizen's Guide to the Nation's Archives: Where the Records Are and How to Find Them; Index; A; B; C; D; E; F; G; H; I; J; K; L; M; N; O; P; Q; R; S; T; U; V; W; X; Y; Z
Record Nr. UNINA-9910453364603321
New York, New York ; ; Oxford, [England] : , : Oxford University Press, , 1996
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Final report of the Advisory Committee on Human Radiation Experiments
Final report of the Advisory Committee on Human Radiation Experiments
Pubbl/distr/stampa New York, New York ; ; Oxford, [England] : , : Oxford University Press, , 1996
Descrizione fisica 1 online resource (655 p.)
Disciplina 616.9897
Soggetto topico Human experimentation in medicine - United States
Radiotherapy - United States
Nuclear medicine - United States
Medical ethics - United States
Radiation victims - United States
Gene therapy - United States
ISBN 0-19-770717-3
0-19-977140-5
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cover; Contents; Remarks; Preface; Introduction: The Atomic Century; PART I: Ethics of Human Subjects Research: A Historical Perspective; Overview; 1. Government Standards for Human Experiments: The 1940s and 1950s; 2. Postwar Professional Standards and Practices for Human Experiments; 3. Government Standards for Human Experiments: The 1960s and 1970s; 4. Ethics Standards in Retrospect; PART II: Case Studies; Overview; 5. Experiments with Plutonium, Uranium, and Polonium; 6. The AEC Program of Radioisotope Distribution; 7. Nontherapeutic Research on Children
8. Total-Body Irradiation: Problems When Research and Treatment Are Intertwined9. Prisoners: A Captive Research Population; 10. Atomic Veterans: Human Experimentation in Connection with Bomb Tests; 11. Intentional Releases: Lifting the Veil of Secrecy; 12. Observational Data Gathering; 13. Secrecy, Human Radiation Experiments, and Intentional Releases; PART III: Contemporary Projects; Overview; 14. Current Federal Policies Governing Human Subjects Research; 15- Research Proposal Review Project; 16. Subject Interview Study; Discussion of Part III
PART IV: Coming to Terms with the Past, Looking Ahead to the FutureOverview; 17. Findings; 18. Recommendations; STATEMENT BY COMMITTEE MEMBER JAY KATZ; OFFICIAL DOCUMENTS; Executive Order; Charter; APPENDICES; Acronyms and Abbreviations; Glossary; A; B; C; D; E; F; G; H; I; L; M; N; P; R; T; U; X; Selected Bibliography; Public Comment Participants; A Citizen's Guide to the Nation's Archives: Where the Records Are and How to Find Them; Index; A; B; C; D; E; F; G; H; I; J; K; L; M; N; O; P; Q; R; S; T; U; V; W; X; Y; Z
Record Nr. UNINA-9910791600903321
New York, New York ; ; Oxford, [England] : , : Oxford University Press, , 1996
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Final report of the Advisory Committee on Human Radiation Experiments
Final report of the Advisory Committee on Human Radiation Experiments
Pubbl/distr/stampa New York, New York ; ; Oxford, [England] : , : Oxford University Press, , 1996
Descrizione fisica 1 online resource (655 p.)
Disciplina 616.9897
Soggetto topico Human experimentation in medicine - United States
Radiotherapy - United States
Nuclear medicine - United States
Medical ethics - United States
Radiation victims - United States
Gene therapy - United States
ISBN 0-19-770717-3
0-19-977140-5
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Cover; Contents; Remarks; Preface; Introduction: The Atomic Century; PART I: Ethics of Human Subjects Research: A Historical Perspective; Overview; 1. Government Standards for Human Experiments: The 1940s and 1950s; 2. Postwar Professional Standards and Practices for Human Experiments; 3. Government Standards for Human Experiments: The 1960s and 1970s; 4. Ethics Standards in Retrospect; PART II: Case Studies; Overview; 5. Experiments with Plutonium, Uranium, and Polonium; 6. The AEC Program of Radioisotope Distribution; 7. Nontherapeutic Research on Children
8. Total-Body Irradiation: Problems When Research and Treatment Are Intertwined9. Prisoners: A Captive Research Population; 10. Atomic Veterans: Human Experimentation in Connection with Bomb Tests; 11. Intentional Releases: Lifting the Veil of Secrecy; 12. Observational Data Gathering; 13. Secrecy, Human Radiation Experiments, and Intentional Releases; PART III: Contemporary Projects; Overview; 14. Current Federal Policies Governing Human Subjects Research; 15- Research Proposal Review Project; 16. Subject Interview Study; Discussion of Part III
PART IV: Coming to Terms with the Past, Looking Ahead to the FutureOverview; 17. Findings; 18. Recommendations; STATEMENT BY COMMITTEE MEMBER JAY KATZ; OFFICIAL DOCUMENTS; Executive Order; Charter; APPENDICES; Acronyms and Abbreviations; Glossary; A; B; C; D; E; F; G; H; I; L; M; N; P; R; T; U; X; Selected Bibliography; Public Comment Participants; A Citizen's Guide to the Nation's Archives: Where the Records Are and How to Find Them; Index; A; B; C; D; E; F; G; H; I; J; K; L; M; N; O; P; Q; R; S; T; U; V; W; X; Y; Z
Record Nr. UNINA-9910810920803321
New York, New York ; ; Oxford, [England] : , : Oxford University Press, , 1996
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Final report on low-volume institutional review boards
Final report on low-volume institutional review boards
Pubbl/distr/stampa [Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 1998
Descrizione fisica 1 online resource (7, A-2, B-2 pages) : illustrations
Soggetto topico Institutional review boards (Medicine) - United States - Evaluation
Human experimentation in medicine - United States
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Low-volume institutional review boards
Record Nr. UNINA-9910707660203321
[Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 1998
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui